MedTrace Logo

Bioequivalence Study of Gliclazide 120 mg Modified Release Tablets

NCT02980757 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2016-12-02

No results posted yet for this study

Summary

The main purpose of this study is to assess comparative bioavailability of two test formulations of Gliclazide 120 mg Modified Release tablets (120 mg gliclazide per modified release tablet) Manufactured By Indeus Life Sciences Pvt. Ltd., Mumbai India (An Affiliate Of Disphar International B.V., The Netherlands) Relative To DIAMICRON MR® 60 mg 2 × (60 mg gliclazide per modified release tablet) Of Les Laboratories Servier Industrie, France in 15 healthy adult subjects under fasting conditions. The second aim is to asses the safety of subjects and to determine other pharmacokinetic data.

Conditions

  • Comparative Bioavailability

Interventions

DRUG

Gliclazide 120 mg MR Tablets Formula A

DRUG

Gliclazide 120 mg MR Tablets

DRUG

Gliclazide 120 mg MR Tablets Formula B

Sponsors & Collaborators

  • Disphar International B.V.

    lead INDUSTRY

Principal Investigators

  • N. Najib, Pharm. Ph.D · International Pharmaceutical Research Center

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-06-30

Countries

  • Jordan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02980757 on ClinicalTrials.gov